| Code | 4813C | ||||||||||
| MA number | 64/0213/17-S | ||||||||||
| Product Form: | int osd 60(6x10)x0,4 ml (obal LDPE-jednodávkový) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Laboratoires THEA, France | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | LDPE single-dose container | ||||||||||
| Route of admin.: | Ocular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 07.08.2017 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Softacort_04.2019.doc
|
| PIL: |
PIL_Softacort_12.2023.pdf
|
| Safety feature | Yes |
| Data update: | 24.08.2022 |
